FDA 510(k) Application Details - K180607

Device Classification Name	More FDA Info for this Device
510(K) Number	K180607
Device Name	Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
Applicant	KRONUS, Inc. 170 S. Seneca Springs Way Suite 105 Star, ID 83669 US Other 510(k) Applications for this Company
Contact	Brian Deis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2018
Decision Date	11/23/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review